Abbreviations
SOC
What is System Organ Class
A list of criteria for entrance into a study. A subject must meet all of one criteria and none of the other criteria to be included in a study.
What is Inclusion/Exclusion Criteria?
The European Spelling of hemorrhage
What is h-a-e-m-o-r-r-h-a-g-e
A Submission of study materials to support an approval to market a product in the US.
What is a Pre-Market Approval?
Well-controlled trials to evaluate efficacy (and safety) in subjects with the disease or condition to be treated, diagnosed, or prevented. These clinical trials usually represent the most rigorous demonstration of a medicine’s efficacy.
What is a Phase 2b Study?
BLA
What is a Biologics License Application?
def: An application used to request approval to market a product in the US.
An independent committee composed of community representatives and clinical research experts that review data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. This committee may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.
What is the Drug Safety and Monitoring Board (DSMB)?
The European spelling of
dyslipidemia
What is d-y-s-l-i-p-i-d-a-e-m-i-a?
DAILY DOUBLE: Document that lists all of the variables and attributes for the database.
What is the Data Dictionary?
This study phase is usually to test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.
What is a Phase 3 Study?
CRF
What is Case Report Form?
DAILY DOUBLE: A written, controlled document which identifies the project specifications, project procedures, database specifications, system implementation requirements and database closure procedures.
What is a Data Management Plan?
The European spelling of diarrhea
What is d-i-a-r-r-h-o-e-a?
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
What is a Protocol?
The study phase where a drug is tested for safety and efficacy in a slightly larger population of subjects who are afflicted by the disease in question.
What is a Phase 2 study?
CDA
What is Confidential Disclosure Agreement?
Document which has been annotated with significant variable information (e.g. names, coding templates, ranges, etc.) as well as visit/page/section identifiers.
What is an Annotated Case Report Form (CRF)?
The European spelling of cesarean
What is c-a-e-s-a-r-e-a-n?
Also: caesarian (UK) / cesarian (US) are other spellings
The written description of the statistical considerations and methods for analyzing the data collected in the clinical study.
What is the Statistical Analysis Plan (SAP)?
A phase of research to describe clinical trials that focus on the safety of a drug.
What is a Phase 1 Study?
GCP
What is Good Clinical Practice?
A global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
The European spelling of defecation
What is d-e-f-a-e-c-a-t-i-o-n?
The project-specific specification for a database. The plan identifies variables (by name, type, format, value list), maps visits, and defines the variable content of datasets.
What is the Database Design Specification (DDS)?
Usually a Phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. This type of study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
What is a Pivotal Study?